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StrokeNCT05985603

Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke

A study testing CIMT Group and Mirror Therapy group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Stroke
What is being tested?
CIMT Group and Mirror Therapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
1 Apr 2023to 15 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A Hemiplegia due to unilateral stroke
  • Sub-acute and chronic stroke
  • Stroke survivors between 21 and 70 years old will be recruited
  • Both genders
  • NIH Stroke scale below 20
  • Mini-Mental State Examination above 24
  • Function in Sitting Test (FIST) above 42/56

Who cannot join

  • Patients with depression who will be unable to cooperate during treatment
  • Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems
  • Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
  • Spasticity of Modified Ashworth Scale (MAS) II or higher
  • Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded.
  • Visual and auditory abnormalities

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Helping Hand Institute Of rehabilitation sciences

    Mansehra, KPK, 21300

Other trials in Pakistan

About this study

There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients.

Conditions
Stroke
Being tested
CIMT Group, Mirror Therapy group
Keywords
CIMT, Mirror Therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIMT GroupOther

    In this group of patients CIMT technique will be used for treatment

  • Mirror Therapy groupOther

    patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.

Study groups in NCT05985603
Study groupRoleWhat they receive
CIMT GroupExperimentalIn this group of patients CIMT technique will be used for treatment
Receives: Other: CIMT Group
Mirror Therapy GroupExperimentalpatient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
Receives: Other: Mirror Therapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NIH Stroke Scale - NIHSS

    It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits

    Measured: 2,4,8 week

  2. Mini-mental state examination

    Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent

    Measured: 2,4,8 week

  3. POMA

    After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.

    Measured: 2,4,8 week

  4. Berg balance scale

    A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.

    Measured: 2,4,8 week

  5. 10 Meter walk test / 10mwt

    Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.

    Measured: 2,4,8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start1 Apr 2023
  3. Primary completion30 Jan 2024
  4. Study completion15 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985603
Sponsor's protocol ID
REC/01665 Bakhtawar Tariq
Status last verified
Nov 2025
First submitted
3 Aug 2023
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oh K, Im N, Lee Y, Lim N, Cho T, Ryu S, Yoon S. Effect of Antigravity Treadmill Gait Training on Gait Function and Fall Risk in Stroke Patients. Ann Rehabil Med. 2022 Jun;46(3):114-121. doi: 10.5535/arm.22034. Epub 2022 Jun 30.

    PubMed 35793900
  • Okonkwo UP, Agbo CF, Ibeneme SC, Igwe ES, Akosile CO, Onwuakagba IU, Emmanuel OC, Maduagwu SM, Ezenwankwo EF, Ekechukwu EN. The Burden and Quality of life of Caregivers of Stroke Survivors with Cognitive Impairment in Selected Healthcare Facilities in Anambra State, Nigeria. Gerontol Geriatr Med. 2022 Sep 27;8:23337214221126329. doi: 10.1177/23337214221126329. eCollection 2022 Jan-Dec.

    PubMed 36189374
  • Wagatsuma M, Kim T, Sitagata P, Lee E, Vrongistinos K, Jung T. The biomechanical investigation of the relationship between balance and muscular strength in people with chronic stroke: a pilot cross-sectional study. Top Stroke Rehabil. 2019 Apr;26(3):173-179. doi: 10.1080/10749357.2019.1574417. Epub 2019 Feb 11.

    PubMed 30741610
  • Khan F, Abusharha S, Alfuraidy A, Nimatallah K, Almalki R, Basaffar R, Mirdad M, Chevidikunnan MF, Basuodan R. Prediction of Factors Affecting Mobility in Patients with Stroke and Finding the Mediation Effect of Balance on Mobility: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 10;19(24):16612. doi: 10.3390/ijerph192416612.

    PubMed 36554493
  • Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.

    PubMed 31326927
  • Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.

    PubMed 31323068
  • Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.

    PubMed 29153043
  • Ju Y, Yoon IJ. The effects of modified constraint-induced movement therapy and mirror therapy on upper extremity function and its influence on activities of daily living. J Phys Ther Sci. 2018 Jan;30(1):77-81. doi: 10.1589/jpts.30.77. Epub 2018 Jan 27.

    PubMed 29410571
  • Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.

    PubMed 36584748
  • E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.

    PubMed 28859603
  • Wang D, Xiang J, He Y, Yuan M, Dong L, Ye Z, Mao W. The Mechanism and Clinical Application of Constraint-Induced Movement Therapy in Stroke Rehabilitation. Front Behav Neurosci. 2022 Jun 21;16:828599. doi: 10.3389/fnbeh.2022.828599. eCollection 2022.

    PubMed 35801093
  • Yoon JA, Koo BI, Shin MJ, Shin YB, Ko HY, Shin YI. Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Ann Rehabil Med. 2014 Aug;38(4):458-66. doi: 10.5535/arm.2014.38.4.458. Epub 2014 Aug 28.

    PubMed 25229024
  • Kim K, Lee S, Kim D, Lee K, Kim Y. Effects of mirror therapy combined with motor tasks on upper extremity function and activities daily living of stroke patients. J Phys Ther Sci. 2016 Jan;28(2):483-7. doi: 10.1589/jpts.28.483. Epub 2016 Feb 29.

    PubMed 27065534

Questions about this trial

What is this clinical trial studying?

A study testing CIMT Group and Mirror Therapy group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIH Stroke Scale - NIHSS (time frame: 2,4,8 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05985603, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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